Trial Outcomes & Findings for A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. (NCT NCT05834348)
NCT ID: NCT05834348
Last Updated: 2025-03-30
Results Overview
The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator.
COMPLETED
5279 participants
From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study
2025-03-30
Participant Flow
Data of eligible participants with non-small cell lung cancer (NSCLC) with age greater than (\>) 18 years at the time of initiating anticancer therapy was collected retrospectively from the 3 national registries: Cancer Registry of Norway (CRN), the Norwegian Drug Registry (NDR) and the Norwegian Patient Registry (NPR) between 1-Jan-2015, and 31-Dec-2022 (maximum up to 96 months). The study was conducted in Norway.
Available data was evaluated as per the study objectives, from 23-Jun-2023 to 23-Jan-2024 (approximately 7 months) in this retrospective observational study.
Participant milestones
| Measure |
Biomarker Cohort
Participants with NSCLC who were positive for biomarkers (epidermal growth factor \[EGFR\] or anaplastic lymphoma kinase \[ALK\] or ROS proto-oncogene 1 \[ROS1\]) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Overall Study
STARTED
|
618
|
4661
|
|
Overall Study
COMPLETED
|
618
|
4661
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Total
n=5279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 13 • n=618 Participants
|
70.7 Years
STANDARD_DEVIATION 9.7 • n=4661 Participants
|
70.2 Years
STANDARD_DEVIATION 10.2 • n=5279 Participants
|
|
Sex: Female, Male
Female
|
385 Participants
n=618 Participants
|
2158 Participants
n=4661 Participants
|
2543 Participants
n=5279 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=618 Participants
|
2503 Participants
n=4661 Participants
|
2736 Participants
n=5279 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows.
The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator.
Outcome measures
| Measure |
Biomarker Cohort
n=398 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=49 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving osimertinib: mToT
|
11 Months
Interval 10.1 to
The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib: mTToT
|
—
|
8.1 Months
Interval 5.6 to 18.8
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving brigatinib: mToT
|
11 Months
Interval 4.7 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving brigatinib: mTToT
|
16 Months
Interval 11.1 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving crizotinib: mToT
|
7 Months
Interval 2.9 to 21.6
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving crizotinib: mTToT
|
19 Months
Interval 10.5 to 37.0
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ROS1+ participants receiving crizotinib: mToT
|
5 Months
Interval 2.4 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ROS1+ participants receiving crizotinib: mTToT
|
18 Months
Interval 4.9 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib: mToT
|
—
|
3 Months
Interval 2.6 to 13.3
|
|
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib: mToT
|
—
|
0.9 Months
Interval 0.9 to 6.5
|
|
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib: mTToT
|
—
|
6.3 Months
Interval 3.7 to 26.7
|
|
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving osimertinib: mTToT
|
14 Months
Interval 11.1 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving other TKI: mToT
|
9.4 Months
Interval 8.2 to 11.2
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving other TKI: mTToT
|
15.8 Months
Interval 13.7 to 18.1
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving alectinib: mToT
|
20 Months
Interval 14.7 to 23.7
|
—
|
|
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving alectinib: mTToT
|
28 Months
Interval 18.0 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
PRIMARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure; "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.
Number of participants were classified and reported according to the Anti-cancer drugs received during first-line, second-line and third-line treatment after diagnosis of NSCLC.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=2656 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in first line
|
104 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving IO and/or ChT in second line
|
53 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in second line
|
25 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving afatinib in second line
|
22 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in third line
|
11 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alecitinib in first line
|
55 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in first line
|
29 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alecitinib in second line
|
14 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving lorlatinib in second line
|
12 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving gefitinib in first line
|
86 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in first line
|
50 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving crizotinib in first line
|
2 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in first line
|
93 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in second line
|
19 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in second line
|
20 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving IO and/or ChT in third line
|
17 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in third line
|
13 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in third line
|
3 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving brigatinib in first line
|
21 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in first line
|
10 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in second line
|
4 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in second line
|
21 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving lorlatinib in third line
|
6 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alectinib in third line
|
4 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in third line
|
2 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in third line
|
8 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving IO/ChT in first line
|
13 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving crizotinib in first line
|
5 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving other drugs in first line
|
4 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving crizotinib in second line
|
2 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving other drugs in second line
|
4 Participants
|
—
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib in first line
|
—
|
23 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in first line
|
—
|
26 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving IO/ChT in first line
|
—
|
2540 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib in second line
|
—
|
7 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in second line
|
—
|
13 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving IO/ChT in second line
|
—
|
22 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving other drugs in second line
|
—
|
16 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in third line
|
—
|
1 Participants
|
|
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving other drugs in third line
|
—
|
8 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number Analyzed" signifies number evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.
Number of participants were classified and reported according to the treatment lines received including first-line, second-line and third-line treatment after diagnosis of NSCLC.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: third line treatment
|
20 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ROS1+: first line treatment
|
22 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: first line treatment
|
335 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: second line treatment
|
139 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: third line treatment
|
44 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: first line treatment
|
115 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: second line treatment
|
51 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ROS1+: second line treatment
|
6 Participants
|
—
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: first line treatment
|
—
|
2589 Participants
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: second line treatment
|
—
|
58 Participants
|
|
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: third line treatment
|
—
|
9 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to date of death (until 31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number Analyzed" signifies number evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.
OS was defined as time from treatment initiation of anticancer therapy to date of death due to any cause. Analysis was performed by Kaplan-Meier method.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Overall Survival (OS)
All participants: 2015-2019
|
19 Months
Interval 16.5 to 21.2
|
5 Months
Interval 4.9 to 5.8
|
|
Overall Survival (OS)
All participants: 2020-2022
|
23 Months
Interval 19.5 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
7 Months
Interval 5.8 to 7.0
|
|
Overall Survival (OS)
EGFR+ participants: 2015-2019
|
18 Months
Interval 15.3 to 19.3
|
—
|
|
Overall Survival (OS)
EGFR+ participants: 2020-2022
|
23 Months
Interval 15.6 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Overall Survival (OS)
ALK+ participants: 2015-2019
|
24 Months
Interval 17.4 to 54.7
|
—
|
|
Overall Survival (OS)
ALK+ participants: 2020-2022
|
NA Months
Interval 23.3 to
The Median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Overall Survival (OS)
ROS+ participants: 2015-2019
|
NA Months
The Median, lower and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
|
Overall Survival (OS)
ROS+ participants: 2020-2022
|
NA Months
The Median, lower and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
The percentage of participants classified according to the disease stages as 3B, 3C, 4A and 4B at the time of diagnosis were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to nearby lymph nodes (LN) \[N\] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N3M0 and T4N2M0). Stage 3C (T3N3M0, T4N3M0), Stage 4A (anyT, anyM and M1a/M1b), Stage 4B (anyT, anyM and M1c). where T1=\<3 cm; T2= 3 to \<5 cm; T3= 5 to \<7 cm; T4= \>7cm. N0=not spread to LN; N1=spread to 1 to 3; N2=spread to 4 to 9; N3=spread \>10 axillary LN. M0= no metastasis; M1a= cancer has spread to other lung; M1b= cancer has as a single tumor outside of the chest, such as to a distant lymph node or an organ such as the liver, bones, or brain; M1c= cancer has spread as more than one tumor outside the chest, such as to distant lymph nodes and/or to other organs such as the liver, bones, or brain.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 3C
|
1.6 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 4B
|
58.6 Percentage of participants
|
55.1 Percentage of participants
|
|
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 3B
|
3.5 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 4A
|
36.2 Percentage of participants
|
36.2 Percentage of participants
|
SECONDARY outcome
Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Percentage of participants classified according to the NSCLC histopathological subtype viz adenocarcinoma, non-small cell carcinoma, large cell neuroendocrine carcinoma were reported in this outcome measure.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Adenocarcinoma
|
94.7 Percentage of participants
|
80.8 Percentage of participants
|
|
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Non-small cell carcinoma
|
5.0 Percentage of participants
|
16.8 Percentage of participants
|
|
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Large cell neuroendocrine carcinoma
|
0.3 Percentage of participants
|
2.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Number of participants classified according to the selected administered non-cancer drugs (anticoagulants and statins) were reported in this outcome measure.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dalteparin
|
99 Participants
|
659 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Edoxaban
|
15 Participants
|
55 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Fondaparinux
|
0 Participants
|
2 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Pravastatin
|
10 Participants
|
34 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Warfarin
|
1 Participants
|
33 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Heparin
|
6 Participants
|
42 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Enoxaparin
|
79 Participants
|
523 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Clopidogrel
|
12 Participants
|
139 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Acetylsalicylic acid
|
91 Participants
|
843 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dipyridamole
|
5 Participants
|
41 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Prasugrel
|
1 Participants
|
8 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Ticagrelor
|
2 Participants
|
14 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Combinations, acetylsalicylic acid
|
0 Participants
|
48 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dabigatran etexilate
|
2 Participants
|
28 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Rivaroxaban
|
14 Participants
|
103 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Apixaban
|
107 Participants
|
498 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Simvastatin
|
47 Participants
|
375 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Fluvastatin
|
1 Participants
|
7 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Atorvastatin
|
97 Participants
|
646 Participants
|
|
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Rosuvastatin
|
11 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.
Number of packs dispensed to participants at the time of dispensing were reported in this outcome measure.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=162 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at first dispensation
|
131 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at second dispensation
|
102 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at third dispensation
|
9 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at fourth dispensation
|
4 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at first dispensation
|
71 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at second dispensation
|
64 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at third dispensation
|
51 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at fourth dispensation
|
49 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at first dispensation
|
1 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at second dispensation
|
3 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at third dispensation
|
9 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at fourth dispensation
|
8 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at first dispensation
|
1 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at second dispensation
|
2 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at third dispensation
|
2 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at fourth dispensation
|
3 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at first dispensation
|
0 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at second dispensation
|
0 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at third dispensation
|
0 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at fourth dispensation
|
0 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at third dispensation
|
86 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at fourth dispensation
|
74 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at first dispensation
|
6 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at second dispensation
|
17 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at third dispensation
|
18 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at fourth dispensation
|
21 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at first dispensation
|
5 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at second dispensation
|
6 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at first dispensation
|
0 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at second dispensation
|
1 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at third dispensation
|
1 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at fourth dispensation
|
1 Participants
|
—
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at first dispensation
|
—
|
14 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at second dispensation
|
—
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at third dispensation
|
—
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at fourth dispensation
|
—
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at first dispensation
|
65 Participants
|
23 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at second dispensation
|
61 Participants
|
15 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at third dispensation
|
57 Participants
|
7 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at fourth dispensation
|
44 Participants
|
5 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at first dispensation
|
4 Participants
|
2 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at second dispensation
|
3 Participants
|
3 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at third dispensation
|
4 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at fourth dispensation
|
9 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at first dispensation
|
3 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at second dispensation
|
5 Participants
|
2 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at third dispensation
|
5 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at fourth dispensation
|
2 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at first dispensation
|
0 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at second dispensation
|
0 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at third dispensation
|
0 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at fourth dispensation
|
0 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at first dispensation
|
41 Participants
|
28 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at second dispensation
|
31 Participants
|
24 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at third dispensation
|
21 Participants
|
15 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at fourth dispensation
|
19 Participants
|
10 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at first dispensation
|
2 Participants
|
2 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at second dispensation
|
4 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at third dispensation
|
6 Participants
|
2 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at fourth dispensation
|
4 Participants
|
1 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at first dispensation
|
8 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at second dispensation
|
7 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at third dispensation
|
4 Participants
|
0 Participants
|
|
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at fourth dispensation
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational studyPopulation: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.
Number of participants classified according to the Norwegian health regions were reported in this outcome measure.
Outcome measures
| Measure |
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
|
|---|---|---|
|
Number of Participants Classified as Per Specific Norwegian Health Regions
Central Norway Regional Health Authority
|
70 Participants
|
665 Participants
|
|
Number of Participants Classified as Per Specific Norwegian Health Regions
Northern Norway Regional Health Authority
|
44 Participants
|
488 Participants
|
|
Number of Participants Classified as Per Specific Norwegian Health Regions
South-East Norway Regional Health Authority
|
341 Participants
|
2427 Participants
|
|
Number of Participants Classified as Per Specific Norwegian Health Regions
Western Norway Regional Health Authority
|
156 Participants
|
1055 Participants
|
|
Number of Participants Classified as Per Specific Norwegian Health Regions
Unknown
|
7 Participants
|
26 Participants
|
Adverse Events
Biomarker Cohort
Non-biomarker Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER